Comparative in vitro and in vivo bioavailability of naproxen from tablet and caplet formulations

✍ Scribed by B. G. Charles; G. A. G. Mogg

• Publisher: John Wiley and Sons
• Year: 1994
• Tongue: English
• Weight: 415 KB
• Volume: 15
• Category: Article
• ISSN: 0142-2782
• DOI: 10.1002/bdd.2510150204

✦ Synopsis

Abstract

A 500 mg dose of naproxen in a caplet formulation (product A) or a tablet (Naprosyn 500, product B) was administered to 14 fasting healthy subjects on two separate occasions, separated by a 1–2 week washout period in an open, randomized crossover. Blood samples were drawn periodically and plasma naproxen concentrations measured by HPLC. The median time T~max~ to reach peak concentration for product A was shorter than that for product B (1·025 h versus 1·5 h) but A and B were similar with respect to median peak plasma concentration C~max~ (77·9 mg 1^−1^ versus 71·4 mg 1^−1^), and average area AUC~0–∞~ under the plasma concentration—time curve (1210·2 mg 1^−1^ h versus 1211·0 mg 1^−1^ h). In vitro parameters (A versus B) of mean dissolution time MDT (5·03 min versus 15·0 min), and time for 70% dissolution T~70~ (6·67 min versus 20·2 min), differed significantly.